Events

Rappel de PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    57242
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2014-06-10
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    If a device is improperly re-installed the collimator may not be properly seated and may loosen and fall. such an event may occur immediately following re-installation during a service maintenance activity but may also occur a few months after a service activity and continued use. a fall of a collimator while the system is in use could result in an injury to a patient or operator. there was a reported incident of a collimator fall which caused a serious patient injury.

Device

PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM
  • Modèle / numéro de série
    Model Catalog: 2259988 (Lot serial: > 10 numbers contact mfg.); Model Catalog: GTC14064PC-2 (Lot serial: > 10 numbers contact mfg.)
  • Description du dispositif
    PROTEUS XR/A GENERAL PURPOSE RADIOGRAPHIC SYSTEM
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)